Are Higher Than FDA Approved SSRI Doses Safe?

July 7, 2020 12:52 PM

My DR has me on 250MG of Sertraline/Zoloft. This is higher than the FDA recommendation. Is this safe?

My DR has me on 250mg of Sertraline/Zoloft for my treatment resistant OCD. This is higher than the FDA recommendation. He claims that he has patients on doses as high as 400MG.

I'm not sure if it is my anxiety/OCD or if I should be concerned about being on such a high dose.

I also believe that there are impacts on dopamine as you get higher.

Thank you

posted by kbbbo to Health & Fitness (4 answers total)

I am not a doctor, but this study may be relevant to your concerns: High-dose Sertraline Strategy for Nonresponders to Acute Treatment for Obsessive-Compulsive Disorder: A Multicenter Double-Blind Trial

Conclusions: Greater symptom improvement was seen in the high-dose sertraline group compared to the 200-mg/day dose group during continuation treatment. Both dosages yielded similar safety profiles. Administration of higher than labeled doses of selective serotonin reuptake inhibitors may be a treatment option for certain OCD patients who fail to respond to standard acute treatment.

posted by brook horse at 1:04 PM on July 7, 2020

There are two definitions of safe for medication: toxicity/overdose and benefit vs side effects. There is no real risk of a toxic overdose with Setraline. Most antidepressants (with the notable exception of MAO Inhibitors) do not have a risk of overdose. So a 250 mg dose is completely safe and there is nothing to worry about. You will not experience permanent problems from having a prescribed dosage higher than the FDA recommended.

It's much more complicated when it comes to benefit/side effects because this is very dependent on the individual and needs to be a discussion you have with your doctor. Personally all of the antidepressants I've tried have caused me noticeably worse side effects at the higher doses. If you feel like you are having more significant side effects on the higher dosage I recommend writing down your experiences so you can show them to the doctor later as it can be difficult to talk about side effects when you feel like the doctor isn't listening. You probably won't notice them until a week or so after the dosage goes up.

The use of higher-then-recommended dosages is one type of "off-label" usage of antidepressants and is fairly common depending on the doctor. Rather it is worth the side effects is not something that can easily be predicted
posted by JZig at 1:16 PM on July 7, 2020 [2 favorites]

There needs to be an official study to get “on-label” (I don’t think that’s really a term), which raises the question of who is going to fund a study. Maybe no one is interested. So use of a drug can be “off label” and also within the medical standard of care.
posted by kerf at 8:54 AM on July 8, 2020

When you say 'treatment resistant', are you talking about increasing dosage, or have you tried CBT? I've been on Sertraline for a few years now, and have found that, whilst it helps with my anxiety and OCD, I also need to use CBT techniques to get back on an even footing. You don't have to see a specialist, as there are a lot of resources out there that might help.

Good luck. And remember that it's your body. If you're not happy with the does being that high, speak to your doctor, and let them know that you don't feel comfortable with it.
posted by Ahdanielsan at 4:55 AM on July 10, 2020